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COVID-19: WHO warns against Gilead’s remdesivir drug approved by US FDA

WHO has expressed concern over the health implication of Gilead Science Inc’s recently approved remdesivir vaccine.

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The World Health Organization (WHO) has warned health officials reviewing Gilead Science Inc’s GILD.O remdesivir against COVID-19 to consider all evidence, including a trial where the medicine failed, before giving its approval to the anti-viral drug.

While making the disclosure during a news conference, Chief Scientist at WHO, Soumya Swaminathan, said that the US regulators, the Food and Drug Administration (FDA), appeared not to have considered the evidence when approving the drug this week.

Backstory

It was reported earlier that the US Food and Drug Administration on Thursday, granted full approval to Gilead’s antiviral drug for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.

The approval came days after a WHO study had discovered the remdesivir anti-viral drug had little or no effect on COVID-19 patients’ length of stay in the hospital or chances of survival. WHO said it failed to prevent deaths among patients.

Swaminathan said that the FDA did not appear to have taken the global health body’s study into account in its approval.

When asked about the FDA move during the news conference, Swaminathan said, “We believe our results are very robust. We hope that people who are doing treatment guidelines in other countries, as well as regulators around the world, will take note of our study results, in addition to the other evidence.”

“Because you need to look at the global evidence for a drug before you make decisions,” she added.

For the remdesivir arm of the WHO’s Solidarity trial, 2,743 patients were given the treatment, compared to 2,708 in the control group.

Gilead’s own study of 1,062 participants, produced data indicating that the treatment cut COVID-19 recovery time by 5 days and helped reduce the risk of death in some patients who were getting oxygen.

The WHO said that the company, which has raised the possibility of bias in the unblinded WHO study because patients and their doctors were aware of which treatments were being used, got initial data showing that remdesivir failed the Solidarity trial in late September. However, the U.S. company said that it had told the FDA about initial Solidarity results.

The FDA did not immediately comment on Swaminathan’s statement that the U.S. agency did not take Solidarity data into account in its approval.

The WHO also disclosed on Friday that its formal guidelines on the use of remdesivir for COVID-19 should be ready for release in 3 to 4 weeks after a separate group within the United Nations health agency would have reviewed data from the study.

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Coronavirus

Covid-19: FG announces 4 phases in the vaccination process against the pandemic

The FG has released phased processes in its vaccination programme against the Covid-19 pandemic.

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The Federal Government has announced the phased processes in its vaccination programme against the Covid-19 pandemic, which is expected to take off on March 5, 2021.

This follows the expected arrival on Tuesday, March 2, 2021, of the first batch of 3,924,000 Covid-19 vaccines under the COVAX initiative from Mumbai, India.

This was disclosed in a statement by the Presidential Task Force (PTF) on Covid-19 on Monday, March 1, 2021.

The PTF said that the vaccine deployment, which is expected to be done by the National Primary Health Care Development Agency (NPHCDA), with assistance from other sister agencies, has been divided into 4 phases.

The 4 phases with the expected activities and vaccination processes include:

1. Phase 1 Vaccination Process

  • All frontline health workers to be vaccinated
  • Vaccines to be deployed to states based on their level of preparedness
  • Cargo planes to be provided for the transport of the vaccines to states.

It should be noted that the 3,924,000 vaccine doses expected to arrive on Tuesday will cater for the initial rollout and Phase 1 Vaccination stage.

2. Phase 2 Vaccination Process (Vaccination of the elderly from 50 years and above)

  • Vaccination of 60 years and above to occur first (Group 1), then
  • Vaccination of 50-55 years (Group 2) to follow

It should be noted that Nigeria is expected to receive another batch of Covid-19 vaccines for this stage.

3. Phase 3 Vaccination Process

  • Vaccination of those between 18 and 49 years with co-morbidities (such as hypertension, diabetes, lung disease, other heart diseases, liver or renal disease, and so on)

4. Phase 4 Vaccination Process

  • Vaccination of the rest of the eligible population between ages 18 and 49 years.

What you should know

Nigeria is expecting the arrival of the first batch of 3,924,000 Oxford/AstraZeneca Covid-19 vaccine on Tuesday, March 2, with vaccination expected to commence on March 5 at National Hospital Abuja for frontline health workers.

The expected arrival of the vaccine is coming after Ghana and Cote’D’Ivoire announced the arrival of the Covid-19 vaccine under the COVAX initiative.

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How to register for Covid-19 vaccination in Nigeria

The NPHCDA has announced guidelines to register for COVID-19 vaccinations.

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The National Primary Health Care Development Agency, NPHCDA, has released guidelines on registering for Covid-19 vaccination in Nigeria.

The guidelines were announced Monday morning in a social media post and they are as follows:

Step 1: Visit https://nphcda.gov.ng/

Step 2: Click on ” covid-19 vaccination e-registration”

  • In the Registration Form for COVID-19 Vaccination you are to fill in; your full names, phone number, email address, date of birth, sex, the type of National ID you have, a residential address which states, the LGA of residence, ward of residence and preferred vaccination site.
  • You are meant to also select your preferred vaccination date and time slot, which ends with a photo update.

After doing the above steps, you will receive a message saying:

“Registration Completed! …Your Vaccination ID is:

Your data is successfully received.

Thank you for taking time to fill the form, you will receive an SMS and email shortly containing your Vaccination No. and other instructions.”

What you should know 

  • The Federal Government confirmed that the first tranche of Covid-19 vaccines will arrive in Nigeria on Tuesday, March 2, 2021.
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FG launches strategy for introduction of Covid-19 vaccine

The FG has launched a strategy for the phased and equitable introduction of the Covid-19 vaccine across the country.

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The Federal Government has launched a strategy for the introduction of the Covid-19 vaccine in a phased and equitable manner across the country.

The strategy code-named, “T.E.A.C.H”, was initiated by the National Primary Health Care Development Agency (NPHCDA), in collaboration with the Federal Ministry of Health (FMOH).

According to a report by the News Agency of Nigeria (NAN), the Minister of Health, Dr Osagie Ehanire, during the inauguration said the launch of T.E.A.C.H and Electronic Management of Immunization Data (EMID) will ensure the smooth rollout of the Covid-19 vaccination campaign across the country.

What the Minister of Health is saying

Ehanire stated, “Our goal is to introduce COVID-19 vaccine in a phased and equitable manner, based on the advice of the WHO and the experience we observe other countries to have made, and ultimately vaccinating all eligible Nigerians within the next two years, to ensure herd immunity.

“We in Nigeria finally have the privilege of joining other countries to start the vaccination, which will prioritise, first those people most at risk of infection due to their exposure in the line of duty.

”Vaccination with safe and effective COVID-19 vaccines is a critical part of the country’s strategy to counter the COVID-19 pandemic and the stop transmission of the virus. No private hospital or organisation has experience in handling this type of vaccine than the NPHCDA,” he said.

The minister also said that vaccines that were not approved by the National Agency for Food and Drug Administration and Control (NAFDAC) would be determined as dangerous and would be seized by the Nigeria Customs Services.

The minister also noted that in less than 24 hours, the first batch of AstraZeneca vaccines would arrive the country from the COVAX Facility and would be deployed.

On his own part, the Director-General of Nigeria Centre for Disease Control (NCDC), Dr Chikwe Ihekweazu, said a lot of work had been done to reduce the casualty of Covid-19 in the country’s population.

Ihekweazu, who was represented by Head of Special Projects and Partnerships at NCDC, Dr Priscilla Ibekwe said that a sister agency, the NPHCDA, was prepared to lead the roll-out of COVID-19 vaccines in the country and NCDC would collaborate with them to ensure a successful campaign.

The Executive Director, NPHCDA, Dr Faisal Shuaib, in his introduction of the T.E.A.C.H Strategy, said it was an Indigenous approach to roll out the Covid-19 vaccine in the country.

Shuaib said that the Country has provided an e-registration link to enable Nigerians to register for the Covid-19 vaccines themselves, to obtain their pre-vaccination numbers and scheduled date

He said that the first phase of the roll-out of the Covid-19 vaccine in the country would target front-line health workers, Covid-19 rapid response teams, laboratory network, petrol station workers and strategic leaders.

According to him, How COVID-19 will be rolled out, Phase 1- healthcare workers, security agents, first responders, petrol station workers, laboratory workers, and strategic political leadership.

What you should know

  • It can be recalled that the Federal Government had announced that Nigeria would receive its first batch of 4 million AstraZeneca Covid-19 vaccine from the COVAX initiative on Tuesday, March 2, 2021.
  • The COVAX Facility which is co-led by Gavi, the Vaccine Alliance, the WHO and the Coalition for Epidemic Preparedness Innovations (CEPI), with UNICEF as a key implementing partner, is a global scheme to procure and equitably distribute vaccines for free, especially among poorer countries, as the world moves to stop the spread of the coronavirus pandemic.
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